India-based Sun Pharma Advanced Research (SPARC) has reported top-line results from two Phase III clinical trials of Baclofen GRS to treat spasticity in patients suffering from multiple sclerosis.
Baclofen GRS is a new once-daily formulation developed using the firm’s gastro-retentive system (GRS) technology, which combines size expansion, adhesion and flotation techniques to allow once-a-day administration.
The results from the CLR_09_21 and CLR_11_03 trials indicated that the drug candidate did not achieve statistical significance, even though a difference in treatment failure rates was observed when compared to placebo.
However, Baclofen GRS is reported to have demonstrated statistically significant secondary endpoint of severity score (SGIS), along with positive data for various other endpoints such as spasm frequency and night-time awakenings.
Sun Pharma Advanced Research CEO Anil Raghavan said: “We are disappointed with the outcomes of these studies and will evaluate the data in greater detail to decide on our next steps.”
The placebo-controlled, randomised, discontinuation Phase III CLR_09_21 trial assessed the efficacy and safety of Baclofen GRS in a total of 293 patients.
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The primary outcome of the trial was proportion of patients who experienced loss of efficacy after discontinuation of Baclofen GRS.
In an additional 135 subjects, the double-blind, randomised, placebo-controlled, parallel group CLR_09_21 trial investigated duration of action of 30mg and 60mg of Baclofen GRS.
During this trial, duration of effect was measured using the total modified Ashworth score over time.
SPARC is currently conducting an open-label extension study with participants from the efficacy and duration of action studies.